FDA PRODUCT CODE · CLASS II
NQX — System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class II (moderate to high risk): general controls and special controls
SPEQ READINGSpecial controls are the distinguishing feature: performance standards, guidance documents, patient registries or postmarket surveillance named for the device type. Find the special controls before designing the test plan — they usually name the tests.
Device is not eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGIndividual malfunction reporting under 21 CFR Part 803 applies. The complaint-handling system has to produce a decision per event, not per period.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Other product codes under 21 CFR 866.1640
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 866.1640 — Antimicrobial susceptibility test powder
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(a) Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
(b) Classification. Class II (performance standards).
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 21, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 866.1640 on eCFR →
Recent clearances
Recent recalls
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.
BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphylococcus aureus. The potential health hazard related to a false positive result from this assay woul
BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant Staphylococcus aureus. The potential health hazard related to a false positive result from this assay woul
The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →